Trial Outcomes & Findings for Capecitabine and Temozolomide for Neuroendocrine Cancers (NCT NCT00869050)
NCT ID: NCT00869050
Last Updated: 2016-07-25
Results Overview
PR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as a reduction of ≥ 30% in the sum of the longest diameter for all target lesions lasting \> 4 weeks, during which no new lesions may appear, when compared with with pretreatment measurements.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
12 months
Results posted on
2016-07-25
Participant Flow
Participant milestones
| Measure |
Capecitabine and Temozolomide
Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).
Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).
Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Capecitabine and Temozolomide
Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).
Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).
Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
|
|---|---|
|
Overall Study
Screen Failure
|
3
|
Baseline Characteristics
Capecitabine and Temozolomide for Neuroendocrine Cancers
Baseline characteristics by cohort
| Measure |
Capecitabine and Temozolomide
n=41 Participants
Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).
Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).
Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
|
|---|---|
|
Age, Customized
Between 30 and 39 years
|
2 participants
n=5 Participants
|
|
Age, Customized
Between 40 and 49 years
|
6 participants
n=5 Participants
|
|
Age, Customized
Between 50 and 59 years
|
22 participants
n=5 Participants
|
|
Age, Customized
Between 60 and 69 years
|
9 participants
n=5 Participants
|
|
Age, Customized
Between 70 and 79 years
|
1 participants
n=5 Participants
|
|
Age, Customized
Between 80 and 89 years
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 28/38 analyzed.
PR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as a reduction of ≥ 30% in the sum of the longest diameter for all target lesions lasting \> 4 weeks, during which no new lesions may appear, when compared with with pretreatment measurements.
Outcome measures
| Measure |
Capecitabine and Temozolomide
n=28 Participants
Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).
Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).
Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
|
|---|---|
|
Number of Participants With Partial Response (PR)
|
9 participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 28/38 analyzed.
CR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as disappearance of all target lesions (primary and metastases), signs, symptoms, and biochemical changes related to the tumor for \>4 weeks, during which no new lesions may appear and no existing lesion may enlarge.
Outcome measures
| Measure |
Capecitabine and Temozolomide
n=28 Participants
Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).
Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).
Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
|
|---|---|
|
Number of Participants With Complete Response (CR)
|
3 participants
|
Adverse Events
Capecitabine and Temozolomide
Serious events: 4 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Capecitabine and Temozolomide
n=38 participants at risk
Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).
Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).
Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
|
|---|---|
|
General disorders
Death
|
2.6%
1/38 • Number of events 1
Number at risk reflects the participants who passed the screening.
|
|
General disorders
Syncope
|
2.6%
1/38 • Number of events 2
Number at risk reflects the participants who passed the screening.
|
|
General disorders
Hypoglycemia
|
5.3%
2/38 • Number of events 3
Number at risk reflects the participants who passed the screening.
|
Other adverse events
| Measure |
Capecitabine and Temozolomide
n=38 participants at risk
Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).
Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).
Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
|
|---|---|
|
Gastrointestinal disorders
Pain abdomen
|
5.3%
2/38 • Number of events 2
Number at risk reflects the participants who passed the screening.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.6%
1/38 • Number of events 1
Number at risk reflects the participants who passed the screening.
|
|
Skin and subcutaneous tissue disorders
Facial flushing
|
5.3%
2/38 • Number of events 2
Number at risk reflects the participants who passed the screening.
|
|
General disorders
Fatigue
|
13.2%
5/38 • Number of events 5
Number at risk reflects the participants who passed the screening.
|
|
General disorders
Dizziness
|
2.6%
1/38 • Number of events 1
Number at risk reflects the participants who passed the screening.
|
|
General disorders
Night sweats
|
5.3%
2/38 • Number of events 2
Number at risk reflects the participants who passed the screening.
|
|
General disorders
Vomiting
|
2.6%
1/38 • Number of events 1
Number at risk reflects the participants who passed the screening.
|
|
Gastrointestinal disorders
Diarrhea
|
13.2%
5/38 • Number of events 5
Number at risk reflects the participants who passed the screening.
|
|
General disorders
Confusion
|
2.6%
1/38 • Number of events 1
Number at risk reflects the participants who passed the screening.
|
|
General disorders
Loss of apetite
|
5.3%
2/38 • Number of events 2
Number at risk reflects the participants who passed the screening.
|
|
Musculoskeletal and connective tissue disorders
Arm and ankle pain
|
2.6%
1/38 • Number of events 1
Number at risk reflects the participants who passed the screening.
|
|
Gastrointestinal disorders
Liver pain
|
2.6%
1/38 • Number of events 1
Number at risk reflects the participants who passed the screening.
|
|
Infections and infestations
Infection
|
13.2%
5/38 • Number of events 5
Number at risk reflects the participants who passed the screening.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
2.6%
1/38 • Number of events 1
Number at risk reflects the participants who passed the screening.
|
|
General disorders
Nausea
|
10.5%
4/38 • Number of events 4
Number at risk reflects the participants who passed the screening.
|
|
General disorders
Cough
|
5.3%
2/38 • Number of events 2
Number at risk reflects the participants who passed the screening.
|
|
General disorders
Constipation
|
10.5%
4/38 • Number of events 4
Number at risk reflects the participants who passed the screening.
|
|
General disorders
Edema
|
5.3%
2/38 • Number of events 2
Number at risk reflects the participants who passed the screening.
|
|
General disorders
Mucositis
|
2.6%
1/38 • Number of events 1
Number at risk reflects the participants who passed the screening.
|
|
General disorders
Tingling lower lip
|
2.6%
1/38 • Number of events 1
Number at risk reflects the participants who passed the screening.
|
|
Surgical and medical procedures
Rash
|
2.6%
1/38 • Number of events 1
Number at risk reflects the participants who passed the screening.
|
|
Immune system disorders
Allergy to dye
|
2.6%
1/38 • Number of events 1
Number at risk reflects the participants who passed the screening.
|
|
General disorders
Anxiety
|
2.6%
1/38 • Number of events 1
Number at risk reflects the participants who passed the screening.
|
|
General disorders
Depression
|
2.6%
1/38 • Number of events 1
Number at risk reflects the participants who passed the screening.
|
|
General disorders
Pruritus
|
2.6%
1/38 • Number of events 1
Number at risk reflects the participants who passed the screening.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
2/38 • Number of events 2
Number at risk reflects the participants who passed the screening.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.6%
1/38 • Number of events 1
Number at risk reflects the participants who passed the screening.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place